Clinical trial · Interventional
Study of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer
A Randomize Controlled Trial of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer
NCT02066688CI-TRIAL-00013813unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Folic acid (FA) and its derivatives (folate) which play a role in nucleotide synthesis and methylation reactions as well as calcium and vitamin D are assumed to be effective in the prevention of colorectal polyps and Colorectal cancer (CRC). The aim of this study is to investigate the roles of FA as well as calcium and vitamin D in the prevention of CRC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcium | Drug | — | UNRESOLVED |
| folic acid | Drug | — | UNRESOLVED |
| folic acid calcium vitamin D3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- FA
- description
- Patients receive oral folic acid pill 1 mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects (FA Arm).
- interventionNames
- Drug: folic acid
- type
- EXPERIMENTAL
- label
- FA+Ca
- description
- Patients receive oral folic acid pill 1 mg+ calcium 1200mg +vitamin D3 250 IU daily for 36 months in the absence of unacceptable toxicity or any other adverse effects(FA+Ca arm).
- interventionNames
- Drug: folic acid calcium vitamin D3
- type
- EXPERIMENTAL
- label
- Ca
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * individuals aged 50-80 years * Patients had undergone complete colonoscopy with no adenoma found * Those who voluntarily sign the consent form after being fully informed and understanding the purpose and procedures of the study, characters of the disease, effect of medications, methods of related examinations, and potential risk/benefits of the study Exclusion Criteria: * Patients who are hypersensitive or intolerant to the drugs * Patients who are intolerant to another colonoscopy examination * Pregnant women, woman during breast-feeding period, or women with expect pregnancy * Patients with diabetes mellitus, severe heart or renal disease，or cancer history * Patients with malignant neoplasm, or suspicious colorectal cancer * Patients who are not able to cooperate * Individuals who are involved in designing, planning or performing this experiment * Patients with medical conditions who are not appropriate to participate the study * Patients who are take aspirin or cyclooxygenase 2 inhibitor （COX2）.
References
Publications (0)
Data not yet available
No reference posted for this study.